Austin, TX /
Clinical, Regulatory, and Quality Affairs – Quality /
At Pattern Bioscience, we’re tackling antibiotic resistance, one of the biggest public health challenges of our time. We use machine learning and microfluidics to quickly recognize the bacteria causing an infection and to predict which drugs will cure the infection.
We are seeking an adaptable, entrepreneurial-minded, and driven Quality Manager to ensure quality system requirements for our In Vitro Diagnostic (IVD) medical device are effectively established and maintained, to report on the quality system performance, and to lead our Quality Team. This role is for you if you enjoy putting together the processes and structures in place to help products become FDA-cleared, understand how to balance and interpret compliance needs with R&D uncertainties in a start-up environment, and get excited about the idea of expanding outside of formal Quality responsibilities to provide support where needed.
Six Month Goals
- Drive hazard analysis and other risk management activities to completion
- Partner with R&D to progress on human factors deliverables such as Use FMEA and formative studies on Sample Preparation
- Champion process validation efforts and help develop process validation master plans for consumables and instruments
- Work with R&D to establish product V&V plans and prioritize execution to support Clinical Trials with a risk-based approach
How You Will Contribute
- Develop, refine, maintain, and deploy the Quality Management System (QMS)
- Train the organization on procedures and overseeing the Training function
- Oversee the quality aspects of the consumable assembly and BSL-2 lab areas
- Provide strategic leadership, reporting, and support with Change Control, Material Review, assessing QMS effectiveness, risk management
- Ensure Document Controls and activities
- Address Supplier Quality issues related to vendor performance, including working with contract manufacturers
- Manage Internal and Supplier Audits and prepare for 3rd Party Audits
- Lead and develop Quality team members
We'd Love to Hear from You If You
- Balance business needs and start-up uncertainties with quality concerns and regulations
- Are adaptable, flexible and self-driven to find creative solutions to addressing quality issues in a new product
- Have worked with medical products in early-stage, clinical, and commercial stages
- Understand technical details in design and manufacturing of electro-mechanical, software-driven medical devices
- Value effective people management and developing team members as demonstrated through a history of training and mentoring teammates
- Communicate clearly and cohesively across disciplines, including utilizing persuasion and data storytelling techniques
Desired Knowledge, Education, and Experience
- FDA regulations related to IVD medical device development and production, particularly 21 CFR 820
- ISO 13485
- Product safety regulations such as IEC-61010
- B.S. in an engineering or life sciences discipline and at least 5 years in a quality-related role handling activities like risk management, supplier quality, change control, and Quality Management Systems
Instead of customizing a cover letter or rewriting a resume to try to feature the attributes and experience this role is seeking, we invite you to fill out the application questions. The hiring manager reviews every response, and the questions allow you to highlight the qualifications that make you a great fit for the role.
Join us! We're excited for what you can bring to our team. Here are a few things we provide to make sure you have a great experience. Learn more about our team by visiting our website.
* Health insurance
* 401k Matching
* Paid Time Off
* The opportunity to make a global impact
To fulfill our mission and build world-changing technology, we’ve put together a diverse, multi-disciplinary top-notch team, a culture of innovation, learning, adaptability, and excellence and environment where people love coming to work.
We value diversity on our teams. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity or expression, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.